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Automated Assessment Using Facial Coding (R44DA042640)

Primary Purpose

Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Advanced Emotion App
Basic Emotion App
Sponsored by
Treatment Innovations
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders

Eligibility Criteria

18 Years - 26 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ages 18-26; outpatient; meets criteria for current SUD based on either verification from a professional or via assessment by our team using DSM-5 criteria; has an iPhone; and is not in an environment that restricts substance use (so that our SUD outcomes will be naturalistic).

Exclusion Criteria:

current uncontrolled psychotic or bipolar disorder as the priority for such clients would be to stabilize them on medication; currently suicidal or violent with intent and/or plan; and/or SUD so severe that detoxification is needed, with any of these criteria reported by the TAY and/or a clinical treater. We will not restrict any treatments, self-help or other care of the TAY.

Sites / Locations

  • Lisa Najavits

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental app

Comparison app

Arm Description

This is the Advanced Emotion App that we initially developed in phase 1 and are now enhancing in phase 2.

This is the Basic Emotion App, which is an alternative intervention app that controls for time and attention.

Outcomes

Primary Outcome Measures

Change in emotion regulation
Composite of the Toronto Alexithymia Scale and the Difficulties in Emotion Regulation Scale
Change in substance use
Brief Addiction Monitor

Secondary Outcome Measures

Change in psychiatric symptoms
Brief Symptom Inventory
Change in coping
Coping Self-Efficacy Scale
Change in stress
Perceived Stress Scale
Change in distress tolerance
Distress Tolerance Scale
Change in functioning
BASIS-32

Full Information

First Posted
May 25, 2018
Last Updated
April 25, 2022
Sponsor
Treatment Innovations
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1. Study Identification

Unique Protocol Identification Number
NCT03551886
Brief Title
Automated Assessment Using Facial Coding
Acronym
R44DA042640
Official Title
Automated Assessment Using Facial Coding
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Treatment Innovations

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Transition-age youth (TAY) from ages 18-26 are vulnerable to substance substance use disorder (SUD). This developmental period, termed "emerging adulthood" includes leaving home, entering college or working for the first time; and for some, aging out of foster care or state custody, which end at age 18. The emerging-adulthood period is prime for experimentation with substances and the development of SUD, and associated problems. A major challenge for TAY is the capacity to regulate their emotions, given the hormone changes and emotional intensity of this stage of life. Indeed, substance use can be a short-term way to regulate emotion. The importance of ER is identified as a core skill that is critical to the successful transition to adulthood. The initial component of ER, accurate identification of emotion, is itself a major challenge. In the phase 1 project a mobile app was developed that uses automated emotion detection to help TAY better recognize their emotions in relation to SUD. We found positive results in our phase 1 study. Phase 2 will see the continuation of the development of the app features. Phase 2 also includes a randomized controlled trial to evaluate the app among TAY with SUD in their natural environment, such as home, and we will conduct pre- and post-evaluation to compare outcomes between the app condition and a control-app condition. The primary outcomes are substance use and emotion regulation. User satisfaction, feedback at the end of phase 2 and app metrics will also be explored. The app can potentially have major public health and clinical impact. It could help improve TAY's ability to become more aware of emotions and understand them in relation to SUD via emotion-focused technoloy. If the product is successful it could be expanded to other populations.
Detailed Description
Transition-age youth (TAY) from ages 18-26 are especially vulnerable to substance use, misuse, and substance use disorder (SUD). This developmental period, termed the "age of instability" and "emerging adulthood" includes tasks such as leaving home, entering college; identifying vocational goals; working for the first time; body and sexuality changes; coalescing with a peer group; and for some, aging out of foster care or state custody, which end at age 18. The emerging-adulthood period is prime for experimentation with substances and the development of SUD, and associated problems such as binge drinking, driving under the influence, accidents, fighting and violence, HIV, gang involvement, suicide and self-harm, and vulnerability to date-rape and other sexual assault. A major challenge for TAY is the capacity to regulate their emotions, given the hormone changes and emotional intensity of this stage of life. Indeed, substance use is often described as a short-term way to regulate emotion and there is a long-standing literature documenting the association between emotion regulation (ER) problems and SUD. The importance of ER is also grounded in the developmental literature in which ER is identified as a core skill that is critical to the successful transition to adulthood. The initial component of ER, accurate identification of emotion, is itself a major challenge, especially for people with SUD as they are often not aware of their feelings or confused about them due to the nature of the disorder as well as mental health disorders that often co-occur with SUD. The phase 1 project developed and evaluated a mobile app that uses exciting new technology (automated emotion detection) to help TAY better recognize their emotions in relation to SUD variables. Highly positive results were found in the phase 1 feasibility / pilot study and are now proposing a phase 2 project to continue this work. In phase 2 the app will continue to be developed based on user experience based on end-user feedback and an expert consultant team. Phase 2 also includes a randomized controlled trial to evaluate the app among TAY with SUD. They will have six weeks to use the app in their natural environment, such as home, and will complete pre- and post-evaluation using validated instrumts to compare outcomes between two conditions: the app condition and a control-app condition. The primary outcomes are substance use and emotion regulation. End-user satisfaction with the app will also be obtained as well as app metrics. The app product could have major public health and clinical impact. It could help improve TAY's ability to become more aware of their emotions and understand them in relation to SUD via an exciting emotion-focused technology innovation. If the product is successful it could also be expanded to other populations. The collaborative team includes experts in SUD, TAY, clinical innovations, technology, and app development.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental app
Arm Type
Experimental
Arm Description
This is the Advanced Emotion App that we initially developed in phase 1 and are now enhancing in phase 2.
Arm Title
Comparison app
Arm Type
Active Comparator
Arm Description
This is the Basic Emotion App, which is an alternative intervention app that controls for time and attention.
Intervention Type
Behavioral
Intervention Name(s)
Advanced Emotion App
Intervention Description
The app is designed to help TAY better recognize their emotions using enhanced features
Intervention Type
Behavioral
Intervention Name(s)
Basic Emotion App
Intervention Description
The app is designed to help TAY better recognize their emotions using basic features
Primary Outcome Measure Information:
Title
Change in emotion regulation
Description
Composite of the Toronto Alexithymia Scale and the Difficulties in Emotion Regulation Scale
Time Frame
baseline and 6 weeks
Title
Change in substance use
Description
Brief Addiction Monitor
Time Frame
baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Change in psychiatric symptoms
Description
Brief Symptom Inventory
Time Frame
baseline and 6 weeks
Title
Change in coping
Description
Coping Self-Efficacy Scale
Time Frame
baseline and 6 weeks
Title
Change in stress
Description
Perceived Stress Scale
Time Frame
baseline and 6 weeks
Title
Change in distress tolerance
Description
Distress Tolerance Scale
Time Frame
baseline and 6 weeks
Title
Change in functioning
Description
BASIS-32
Time Frame
baseline and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ages 18-26; outpatient; meets criteria for current SUD based on either verification from a professional or via assessment by our team using DSM-5 criteria; has an iPhone; and is not in an environment that restricts substance use (so that our SUD outcomes will be naturalistic). Exclusion Criteria: current uncontrolled psychotic or bipolar disorder as the priority for such clients would be to stabilize them on medication; currently suicidal or violent with intent and/or plan; and/or SUD so severe that detoxification is needed, with any of these criteria reported by the TAY and/or a clinical treater. We will not restrict any treatments, self-help or other care of the TAY.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Najavits
Organizational Affiliation
Treatment Innovations
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lisa Najavits
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States

12. IPD Sharing Statement

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Automated Assessment Using Facial Coding

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